Global Medical Device Regulatory and QMS Consulting Specialists

Emergo's roots go back to 1997. Rene van de Zande, CEO of Emergo, founded the company shortly after the implementation of the new European Medical Devices Directive (93/42/EEC). His goal was to help US medical device companies obtain CE Marking and export their products to Europe.

Since then, Emergo has expanded to become a leading consultancy with more than 2,500 medical device and IVD clients worldwide. In 2017, Emergo was purchased by UL. Today we maintain offices in 25+ countries, offering a wide range of compliance services. We assist companies with regulatory strategy, device registration, quality management system compliance and in-country regulatory representation.

7 reasons to choose Emergo

1. We Can Help You Access Markets More Efficiently

Brazil, China, Japan, Mexico, Korea...which market is next for you? We help medical device manufacturers strategically leverage their existing regulatory approvals so they can enter new markets quickly and cost effectively. Hiring an experienced consultant with a global view and local expertise is critical. While we cannot control how fast Ministries of Health review registration applications, we'll do everything we can to get you in line for approval as quickly as possible.

2. One Call Gets You Access To 95% Of The Global Medical Device Market

There are hundreds of qualified consultants who can help you with compliance in one or two markets. Emergo can help you prioritize and access more than 55 countries accounting for 95% of the global healthcare spending. Our experienced consultants in 30 countries have local market intelligence, established industry contacts and knowledge of local business customs. In many cases, having this local expertise is the difference between success and frustration. There is no need for you to hire multiple consulting firms or entrust your registrations to numerous distributors or unaffiliated consultants. "One call. One trusted partner. Worldwide access."

3. We Likely Have Experience With Your Device Category

We serve thousands of medical device and IVD clients making a huge variety of products. Chances are very good that our consulting team has experience with your specific device or the category. Our consulting expertise runs especially deep in areas such as orthopedics, cardiovascular, dental, radiology, wound care and IVDs.

4. We Give You Full Control Over How You Distribute Your Devices

Don't get stuck with a poorly performing distributor because they control your registration in a specific market. More than 2,000 companies use us as their independent regulatory representative and registration holder. We have no involvement in selling products so using Emergo as your regulatory representative allows you to bring on new distributors as you wish, and terminate those who do not perform. This is important in markets including Europe, Brazil, Japan, Mexico and China.

5. Your Intellectual Property Is Safe With Us

Do you trust your distributor with your intellectual property? It's an especially critical issue for new and innovative technology. Emergo has nothing to gain by sharing your IP. Others might. When you work with us, your documents, manuals, certificates, dossiers and project related files are made available on a secure, password protected web-based platform accessible only to employees and key consultants working on your project. Your data is confidential and none of it is stored on desktop computers where it could be lost or stolen. Plus, everyone working on your project has access to the same updated information online.

6. We Provide Accurate, Realistic Project Budgets

Nobody likes surprises when it comes to invoices. Our consultants all carefully track the number of hours spent on each project and use this knowledge to more accurately estimate new projects. Barring unforeseen complications, the majority of our projects finish within the original budget and you only pay for the hours we spend on your project.

7. We Provide Frequent Updates And Peer Review All Projects

We have dedicated project management teams in North and South America, Europe and Asia. They all use the same project management platform. Our teams provide frequent updates on projects so you know expected time to completion, and the remaining budget. Plus, we always have a "fresh set of eyes" examine all prepared documents for quality, accuracy and completeness before they are sent to a client. All departments have documented work procedures, and yearly audits, peer reviews and client surveys help us improve ongoing efficiency. Independent consultants and distributors rarely offer this level of quality control.

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.